Impact of Angiotensin II Receptor Blockers Treatment in Patients With COVID 19 (COVID-ARA2)

Sponsor

University Hospital, Angers (Other)

Overall Status

Unknown status

CT.gov ID

NCT04337190

Collaborator

(none)

100

Enrollment

Location

8.1

Anticipated Duration (Months)

12.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The actual pandemic infection related to SARS-CoV2 results in viral pneumonitis (COVID-19), that may, in the more severe cases, lead the patients to the intensive care unit (ICU). The more frequent presentation is acute respiratory distress syndrome (ARDS).

To penetrate cells, SARS-CoV2 uses Angioconvertase type 2 (ACE2) as a cellular entry receptor.

ACE2 belong to the renin-angiotensin-aldosteron system (SRAA), and ACE2 levels are directly modified when SRAA inhibitors are administred to patients, and ACE2 level increases particularely with Angiotensin II Receptor blockers (ARA2) use.

The aim of our study is to determine ACE2 level and activity in patients with SARSCoV2 infection admitted to the intensive care unit (ICU).

COVID ARA2 is a propsective cohort of patient with blood sampling at the day of admission, day 3 and day 7.

Condition or Disease	Intervention/Treatment	Phase
COVID Acute Respiratory Distress Syndrome	Biological: blood sampling

Detailed Description

To penetrate cells, SARS-CoV2 uses Angioconvertase type 2 (ACE2) as a cellular entry receptor.

The aim of our study is to determine ACE2 level and activity in patients with SARSCoV2 infection admitted to the intensive care unit (ICU).

COVID ARA2 is a propsective cohort of patient with blood sampling at the day of admission, day 3 and day 7.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Impact of Previous Treatment With Angiotensin II Receptor Blockers in Patients With SARS-Cov2 Infection Admitted to the Intensive Care Unit on Survival and Severity of the Disease (COVID-ARA2)

Actual Study Start Date :

Apr 3, 2020

Anticipated Primary Completion Date :

Oct 6, 2020

Anticipated Study Completion Date :

Dec 6, 2020

Outcome Measures

Primary Outcome Measures

ACE2 level change over time [at the day of admission, day 3 and day 7]
ELISA test (Higher the ACE2 level, higher the virus penetrate cells)

Secondary Outcome Measures

ACE2 activity over time [at the day of admission, day 3 and day 7]
Ratio angiotensin (1-7)/angiotensin(1/10) (Higher Ratio angiotensin (1-7)/angiotensin(1/10), higher is ACE2 activity)
Mortality at day 28 [day 28]
Mortality at day 28
ARDS severity [from the day of admission to day 7]
PaO2/FiO2 ratio (ARDS is severe when <100, moderate when between 100 and 200, mild when >200)
Duration of mechanical ventilation [from the day of admission to day 28]
Day under mechanical ventilation
Need for prone positionning [from the day of admission to day 28]
Need for prone positionning
Need for extracorporeal membran oxygenation [from the day of admission to day 28]
Need for extracorporeal membran oxygenation
Use of paralytic agents [from the day of admission to day 28]
Need for use of paralytic agents
Need for renal replacement therapy [from the day of admission to day 28]
Need for renal replacement therapy
Need for vasoactive drugs (norepinephrine, dobutamine,epinephrine) [from the day of admission to day 28]
Need for vasoactive drugs
Sequential Organ Failure Assessment (SOFA) score [from the day of admission to day 7]
The SOFA score evaluates the severity of patients through 6 items: respiration (PaO2/FiO2 ratio); coagulation (platelets count); liver (bilirubin); Cardiovascular (hypotension); Central nervous system (coma glasgow score) and Renal (creatinine serum level). Score ranges from 0 to 24, a higher score indicates higher severity and probability of death
Number of session(s) of prone positionning [from the day of admission to day 28]
Number of session(s) of prone positionning
Duration of extracorporeal membran oxygenation treatment [from the day of admission to day 28]
Duration of extracorporeal membran oxygenation treatment
Type of vasoactive drugs [from the day of admission to day 28]
Several vasoactive agents may be used: norepinephrine, dobutamine, epinephrine, vasopressin analogues...
Duration of vasoactive treatment [from the day of admission to day 28]
Duration of vasoactive treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

admission to the intensive care unit,
with a proven COVID infection, responsible for acute respiratory failure
agree with participation to the study.

Exclusion Criteria:

aged under 18
under legal protection
pregnant or breastfeeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Angers	Angers		France	49933

Sponsors and Collaborators

University Hospital, Angers

Investigators

Principal Investigator: Pierre Asfar, MD, PhD, CHU Angers, service de médecine intensive réanimation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Angers

ClinicalTrials.gov Identifier:

NCT04337190

Other Study ID Numbers:

COVID-ARA2

First Posted:

Apr 7, 2020

Last Update Posted:

Apr 10, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Acute Lung Injury

Study Results

No Results Posted as of Apr 10, 2020